Symptom Monitoring using Patient-Reported Outcomes to Optimize Medication Use (SyMPTOM)

For the more than 200,000 women who develop hormone receptor positive breast cancer yearly, endocrine therapy for at least five years reduces cancer recurrence by nearly 50% and increases overall survival. Yet almost half of patients prescribed endocrine therapy fail to take all their pills. Education and reminder-based studies in this and other clinical settings have had disappointingly small effects on adherence, and more complex interventions have proven difficult to sustain. In this proposal, we focus on the pain, menopausal, and other symptoms that women describe as major barriers to endocrine therapy adherence. We have drawn on two complementary sets of research findings: first, trials in chemotherapy settings recently reported that routine symptom monitoring and management can improve a number of outcomes, including survival; and second, research from non-oncologic chronic care settings has shown that a number of outcomes can be improved with outreach to high-risk patients by nonphysician providers in between physician visits. We propose an intervention targeting high-risk patients who already have poor adherence to endocrine therapy. In a randomized study, we will routinely collect patient-reported symptom data from patients. Clinical pharmacy teams will support patients to manage symptoms and address other barriers so they can continue daily medications. The primary objective of the study is to improve adherence, with specific aims as follows: Aim 1: Assess the impact of symptom monitoring and management with clinical pharmacist led follow-up (the intervention) on patient adherence to oral endocrine therapy. We will assess the impact of a 12-month intervention on adherence and evaluate adherence again at 24 months to assess intervention durability. Aim 2: Describe the impact of the intervention on symptoms. We will model the average trajectories of patientreported outcomes over time by study group. We will also model symptoms by adherence level since side effects may increase if adherence increases. Aim 3: Explore the impact of the intervention on potential mechanisms for improvement of adherence. We will use mediation analysis to examine the relationships between the intervention and proposed mechanisms including 1) baseline symptom severity 2) self-efficacy to manage medications and symptoms, 3) team communication with the patient, and 4) social support. If successful, this study has the potential to improve care for thousands of women. Many newly approved oncologic medications are oral agents, so this intervention would also be an important model for other conditions and could inform the design of oncologic care delivery.